BEUDAMED
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    OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31

    FDA 510(k)
    FDA Unclassified ·Unknown

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496060987·MICROMASSAGE COMFORT, SIZE ML, NERO, GRADUATED ...

    BioQuick®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70609871·BioQuick-Brackets Roth .022" 100 Brackets

    KSEA MINIATURE TELESCOPE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VFSS IMAGER, MODEL SIS-300

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Injury ·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009

    CBL 5 LEAD, SNAP, SHILD AAMI, LIBM RGD

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013

    HUDSON HEATED-WIRE NEONATAL VENTILATOR CIRCUIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·March 14, 2011

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 12, 2008

    EVOLUT FX VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·July 9, 2025

    Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

    Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011